During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.
For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.
To read the full text of the article by Duane Morris , visit the MD+DI website.
On January 9, 2020, the U.S. Food and Drug Administration announced that it will host an all-day public forum to discuss testing methods for asbestos in talc and cosmetic products containing talc on February 4, 2020.
According to the FDA, the purpose of the meeting is to discuss testing methods, terminology, and criteria that can be used to characterize and measure asbestos, as well as what the FDA preliminarily states may be “other potentially harmful elongate mineral particles (EMPs)” that may contaminate talc and cosmetics products that contain talc.
Read more in the Beauty and Cosmetics category of the Duane Morris Fashion, Retail and Consumer Branded Products blog.
It is no secret that third-party litigation funding, or TPLF, has become an increasingly common practice. One area particularly affected by this trend is that of mass tort actions and multidistrict litigations, where funding is now more than ever being utilized to finance voluminous and prolonged proceedings.
While courts have historically been reluctant to require disclosure of funding agreements and information, precedent suggests that different approaches may be warranted in the MDL context because of considerations unique to those proceedings — including potential for bias, distortions of control and decision-making as between litigants and funders, and conflicts of interest between funders and the judiciary.
Against this backdrop, advocates of disclosure have taken a proactive role in seeking further changes to rules of discovery and disclosure to address these issues. Litigants should be aware of these emerging efforts toward change, and the reasons underlying them, as the use of litigation funding continues to rise.
To read the full text of this article by Duane Morris attorneys Anne A. Gruner, Justin M. L. Stern and Nicholas M. Centrella Jr., please visit the firm website.
On August 26, 2019, Cleveland County, Oklahoma, District Judge Thad Balkman delivered his highly anticipated ruling in the state of Oklahoma’s lawsuit against certain pharmaceutical companies responsible for manufacturing and marketing prescription opioid medications. Because the other pharmaceutical companies named in the state’s case settled with the Attorney General’s Office earlier this year, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals remained the primary subjects of the evidence at trial and the focus of the attention surrounding Judge Balkman’s then-forthcoming ruling.
As Judge Balkman stated in the published judgment, the defendants knowingly and misleadingly marketed their highly addictive prescription opioids, and by doing so caused harm for which the state could seek redress, as their “actions annoyed, injured, or endangered the comfort, repose, health or safety of Oklahomans.”
View the full Alert on the Duane Morris LLP website.
In 2016, it was muted monochromatic makeup. The next year ushered in a spectrum of sunset reds and dusty pinks, and 2018 was the year of technicolor highlighter. With bold beauty trends on the rise, it’s no surprise that 2019 has been declared the year of neon. Pinterest reports that searches for “neon eyeshadow” jumped a whopping 842% over the past few months. For fans, especially Gen Zers, the look is a celebration of fun, commitment-free expression: Daydream, create, wash it off, and repeat. But what happens when experimenting with the latest beauty trends could put your health at risk?
As for the brands that feature a disclaimer not to use on eyes, and then turn around and show models wearing the product on their eyes, Kelly Bonner, associate attorney at Duane Morris LLP in Philadelphia, had this to say: “All labelling must be truthful, not misleading, and contain all required information in a prominent and conspicuous place. Determining whether a label is misleading requires considering whether it contains deceptive representations, or leaves out material facts or consequences resulting from the intended use of the product.”
To read the full text of this article quoting Duane Morris attorney Kelly Bonner, please visit the Refinery29 website.
In recent months, reports of asbestos-contaminated cosmetics have illustrated the enduring challenges of manufacturing and marketing cosmetics as safe for consumers, particularly teens, children and expectant mothers. This is especially true where still-developing science, emotion and rapidly disseminated information (and misinformation) all play critical roles in shaping public perception, even influencing jury outcomes.
This article explores the potential legal challenges for supply chain participants arising from contaminated cosmetics, as well as significant proposals to change the way the U.S. Food and Drug Administration regulates cosmetic safety.
To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website.
On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”
View the full Alert on the Duane Morris LLP website.
Additive manufacturing, commonly known as 3-dimensional (3D) printing, has been billed as the new industrial revolution. It is a lofty prediction; but we are seeing this prognostication materialize. Everyday consumer products ranging from children’s toys to running shoes are being 3D printed, sometimes right in consumer stores or at home. More and more manufacturers have begun or are exploring additive manufacturing options for their products. 3D-printed products even won an Oscar, when Ruth Carter won Best Costume Design for her work in the movie Black Panther, where portions of Carter’s costumes were 3D printed. From everyday consumer products, to its appearance on the red carpet, 3D printing has arrived.
Recognizing the potential advantages, endless possibilities, and unique manufacturing capabilities offered by 3D printing, more and more medical device manufacturers are entering this new field of technology. However, industry standards and regulations lag behind the pace of innovation. The unique aspects and potential availability of additive manufacturing raise novel products liability issues that may impact traditional product liability litigation doctrines. This article examines the current status of additive manufacturing as well as potential issues and uncertainties it raises for the future of product-liability litigation.
To read the full text of this article by Duane Morris partner Sean K. Burke, please visit the MD&DI Qmed website.
The most recent talc verdicts have demonstrated some traction in defeating claims based on certain go-to defense strategies, including personal jurisdiction dismissals, the use of expert testimony and Daubert motions discrediting scientific causation, and even requests to jurors to use their “common sense” in evaluating scientific evidence. However, there is another tool that defense attorneys should consider in talc cases: federal preemption.
Part of the mass appeal of talc cases lies in the prevalence of talc-based products in the marketplace, due to the numerous uses for talc in a variety of consumer products across cosmetics, over-the-counter (OTC) drugs, and even foods. As talc litigation expands into products that may be regulated as OTC drugs, defense counsel should consider the options that they might have in invoking federal preemption as a defense strategy. While the defense remains untested, there is a sound basis for its application. This article will discuss the federal U.S. Food and Drug Administration (FDA) regulatory scheme that is applicable to talc-based products and when federal preemption may support an argument for defeating conflicting state law claims against talc-containing OTC drugs.
To read the full text of this article by Duane Morris attorneys Anne A. Gruner and
Nicholas M. Centrella, Jr., please visit the Duane Morris website.